BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 19094989 · Received April 12, 2024

    Report

    Report Number
    2249723-2024-01502
    Event Type
    Malfunction
    Date Received
    April 12, 2024
    Date of Event
    March 29, 2024
    Report Date
    April 2, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    **UDI RELATED DATA QUALITY UPDATES ONLY** PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID (D1, D2, D3, D4, G4, H4, H5)

    Additional Manufacturer Narrative · 0

    UPDATED DATA: B4, G3, G6, H1, H2, H11. CORRECTED DATA: D1, D2, D3, D4.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D8, D9, G1(CONTACT PERSON ¿ MFG SITE), G3, G6, H2, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) VISITED ONSITE AND CONFIRMED WHEN FIBER OPTIC MODULE WAS CONNECTED A SENSOR FAILURE OCCURRED. REPLACED THE FIBER OPTIC MODULE (D997-00-1169) ALONG WITH JUMPER CABLE (D012-00-1808). AFTERWARDS FAILURE WAS NO LONGER PRESENT. VERIFIED UNIT CALIBRATED AND PASSES ALL FUNCTIONAL AND SAFETY TESTS PER FACTORY SPECIFICATIONS, UNIT RETURNED TO CUSTOMER. PATIENT WAS INVOLVED; NO OTHER INFORMATION WAS PROVIDED. PATIENT WAS NOT HARMED AND THERAPY WAS NOT DELAYED. UNIT WAS TAKEN TO TRANSPORT BASE FOR FURTHER INVESTIGATION BY TRANSPORT MANAGER (B)(6). THE FAILURE ANALYSIS AND TESTING DEPARTMENT PERFORMED A VISUAL INSPECTION OF THE PARTS RECEIVED AND FOUND THAT ALL THE PARTS ARE IN GOOD CONDITION. THE FAILURE ANALYSIS AND TESTING DEPARTMENT INSTALLED PART NUMBER: 0997-00-1169 FIBER OPTIC MODULE SERIAL NUMBER: (B)(6) FISO AND PART NUMBER 0012-00-1808 FIBER OPTIC CABLE SERIAL NUMBER (B)(6) FISO IN THE CARDIOSAVE TEST FIXTURE SERIAL NUMBER (B)(6). AND TESTED JOINTLY AND SEPARATELY TO FACTORY SPECIFICATIONS IN ACCORDANCE WITH CARDIOSAVE SERVICE MANUAL NUMBER 0070-00-0639 REVISION R. THE FAILURE ANALYSIS AND TESTING DEPARTMENT VERIFIED THE FIBER OPTIC FAILURE EXPERIENCED BY THE CUSTOMER. THE FAILURE ANALYSIS AND TESTING DEPARTMENT TESTED PART NUMBER: 0997-00-1169 AND IT PASSED ALL TESTS. BUT PART NUMBER: 0012-00-1808 FAILED THE TESTS. RETAINING THE FIBER OPTIC CABLE IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE 0002-07-D008 REV AR. BOARD WAS RE-TESTED AT FCT. RESULT: FAILED STEP 3.0.0 EEPROM PROGRAMMING, U2. PERFORM TROUBLESHOOTING ON THE BOARD -FOUND U2 DEFECTIVE PROBABLE ROOT CAUSE FOR THIS PART IS IMPOSSIBLE TO DEFINE. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER 0002-07-D008 REV. AR. FAILURE ANALYSIS RECEIVED FROM THE SUPPLIER FOR THE PART 0992-00-1017. ROOT CAUSE FOR THIS PART IS NOT CONFIRMED. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER 0002-07-D008 REV. AS.

    Description of Event or Problem · 0

    CUSTOMER STATED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD A FIBER OPTIC FAILURE DURING USE WHILE TRANSPORTING A PATIENT. PATIENT WAS ABLE TO BE TRANSFERRED TO ANOTHER PUMP TO CONTINUE THERAPY. THERE WAS NO PATIENT HARM.

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1509789 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-53 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN.